Baird Medical and Alpmed Announce FDA 510(k) and EU CE Submissions for Irreversible Electroporation (IRE) System

Worldwide commercial rights give Baird Medical a potential addition to its ablation portfolio, subject to regulatory review.

Rhea-AI Summary

Baird Medical (NASDAQ: BDMD) announced that partner Alpmed submitted U.S. and European regulatory applications for an irreversible electroporation (IRE) system.

The applications, submitted in the fourth quarter of 2026, seek FDA 510(k) clearance and EU CE marking. The system is designed for soft tissue ablation, using electrical pulses rather than heat to destroy cells. Baird Medical holds worldwide commercial rights and is leading global regulatory interactions during review. The companies target potential clearance and CE marking in 2027, subject to the respective regulatory reviews. The submissions were completed less than three months after the cooperation agreement was signed.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointAlpmed submitted U.S. FDA 510(k) and EU CE applications for the partnered IRE system in fourth-quarter 2026.
• Moderate pointBaird Medical holds worldwide commercial rights for the IRE system.
• Minor point. Forward-looking: it has not happened yet and may not happen.The companies target potential FDA clearance and EU CE marking in 2027.

Negative

• Minor pointPotential clearance and CE marking remain subject to the respective regulatory reviews.

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Market Reaction – BDMD

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Key Figures

Submission timing: Q4 2026 Clearance and marking target: 2027

Submission timing

Q4 2026

FDA 510(k) and EU CE conformity assessment applications submitted

Clearance and marking target

2027

Potential U.S. FDA 510(k) clearance and EU CE marking, subject to review

Historical Context

1 past event · Latest: Oct 05

1 event

1. Oct 05

   IRE partnership

   24h Move

   -1.1%

   Alpmed partnership established a global development and commercialization program for irreversible electroporation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

510(k) premarket notification, irreversible electroporation, microwave ablation

3 terms

510(k) premarket notification regulatory

"submitted a 510(k) premarket notification to the U.S. Food and Drug Administration"

A 510(k) premarket notification is a regulatory submission to the U.S. Food and Drug Administration that shows a new medical device is as safe and effective as an existing, legally marketed device. Think of it like demonstrating your new model performs like a trusted older model so it can be sold; for investors, 510(k) clearance is a key hurdle that affects how quickly a device can reach market, development cost, and the level of regulatory risk in a medical-device investment.

irreversible electroporation medical

"for an irreversible electroporation (IRE) system"

Irreversible electroporation is a medical tissue‑ablation technique that uses short, high‑voltage electrical pulses to create permanent microscopic holes in cell membranes, causing targeted cells to die while leaving nearby structural tissue and blood vessels largely intact. Investors should care because it is a non‑thermal alternative to surgery or heat‑based ablation, so its clinical adoption, regulatory approvals, device sales, reimbursement policies and competitive position can materially affect the revenue and valuation of companies that develop or sell these medical technologies.

microwave ablation medical

"a global leader in microwave ablation (MWA) technology"

Microwave ablation is a medical procedure that uses focused microwave energy to heat and destroy abnormal tissue, such as tumors, through a needle-like probe inserted into the body; think of it as using a tiny, targeted microwave oven to cook away problem cells without large incisions. It matters to investors because it represents a growing category of minimally invasive treatments that can reduce hospital stays, create demand for specialized devices and disposables, and influence reimbursement and adoption trends in healthcare markets.

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510(k) Application to U.S. Food and Drug Administration and Application for European Union Certification Submitted in Fourth Quarter 2026

NEW YORK, Nov. 05, 2026 (GLOBE NEWSWIRE) -- Baird Medical Investment Holdings Limited (NASDAQ: BDMD) (“Baird Medical” or the “Company”), a global leader in microwave ablation (MWA) technology, today announced that its strategic partner, Tianjin Yuanshan Medical Technology Co., Ltd. (“Alpmed”), has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) and an application for CE conformity assessment in the European Union for an irreversible electroporation (IRE) system. The system is designed for soft tissue ablation, with the potential to be used to treat a range of tumor types, and is being advanced under the companies’ previously announced partnership.

IRE is an advanced, minimally-invasive, non-thermal ablation technology that uses high-voltage electrical pulses to disrupt cell membranes and induce cell death. This mechanism may offer advantages when treating tissue near sensitive anatomical structures.

Under the partnership with Alpmed, Baird Medical is leading global regulatory interactions during the respective review processes, and holds worldwide commercial rights for the IRE system. The companies are targeting potential U.S. FDA 510(k) clearance and EU CE marking in 2027, subject to the outcome of the respective regulatory review processes.

“The U.S. 510(k) submission and EU CE conformity assessment application represent two significant milestones as we continue working to expand our portfolio of minimally-invasive ablation platforms beyond our core MWA technology. If cleared, adding IRE to our portfolio could create additional opportunities to address indications for which thermal ablation may not be the optimal solution,” said Haimei Wu, Chairwoman and CEO of Baird Medical. “That these submissions were completed less than three months after the signing of the cooperation agreement with Alpmed is a testament to the capabilities and commitment of our teams as well as the broader potential of this strategic partnership. We look forward to productive interactions with the regulators in the U.S. and EU during the respective review processes, and to providing updates on our progress, as appropriate.”

About Baird Medical

Baird Medical is a global, pioneering medical device company specializing in minimally invasive ablation technologies for a range of solid tumors. The Company’s lead product, a microwave ablation (MWA) system, is FDA-cleared for soft tissue ablation and is being launched in the U.S. primarily for the treatment of benign thyroid nodules. In addition, the Company is expanding its minimally invasive technology portfolio, including IRE-based products and an AI-powered robotic ablation system.

Baird Medical's MWA solutions have been adopted by a growing number of leading U.S. institutions and private practice groups, including the Mayo Clinic, Columbia University Medical Center, and The George Washington University Hospital. The company is rapidly expanding its global commercial footprint, with sales now reaching markets across multiple continents.

About Alpmed

Alpmed is a member company of Saixiang Group and is under common control with Tianjin Saixiang Technology Co., Ltd. (SZSE: 002337), a publicly listed company. Alpmed focuses on the research, development, and innovation of IRE technology and is an early mover and one of the leading companies in the field. The company has established an IRE technology portfolio across four areas: tumor ablation, cardiac electrophysiology, peripheral vascular intervention, and interventional pulmonology.

In oncology, Alpmed has commercialized China’s first domestically developed IRE ablation product for malignant liver and pancreatic tumors. The company is also advancing applications of its technology in prostate, thyroid, breast, and other solid tumor indications.

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Baird Medical's future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as "may", "could", "should", "expect", "intend", "might", "will", "estimate", "anticipate", "believe", "budget", "forecast", "intend", "plan", "potential", "predict", or "continue", or the negatives of these terms or variations of them or similar terminology. Forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Baird Medical and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Baird Medical does not undertake any duty to update these forward-looking statements.

Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors, including, without limitation: (1) the risk that Baird Medical may not be successful in expanding its business in China or the United States; (2) changes in general economic conditions; (3) regulatory conditions and developments; (4) changes in applicable laws or regulations; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings instituted against Baird Medical or others; and (6) other risks and uncertainties from time to time described in the Registration Statement relating to the Business Combination and the transition report, including those listed under the sections titled "Risk Factors" therein, and in ExcelFin's other filings with the SEC.

The foregoing list of factors is not exclusive. Additional information concerning certain of these, and other risk factors is contained in ExcelFin's most recent filings with the SEC and in the Registration Statement described above filed by Baird Medical in connection with its business combination with ExcelFin. All subsequent written and oral forward-looking statements concerning Baird Medical, the business combination described herein, or other matters attributable to Baird Medical or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Baird Medical expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

Contact:

Lee Roth
Burns McClellan for Baird Medical
Lroth@burnsmc.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What regulatory applications did Alpmed submit for Baird Medical's partnered IRE system?

Alpmed submitted a 510(k) premarket notification to the U.S. FDA and an application for EU CE conformity assessment in the fourth quarter of 2026. The partnered system is designed for soft tissue ablation.

When do Baird Medical and Alpmed target regulatory clearance for the IRE system?

The companies target potential U.S. FDA 510(k) clearance and EU CE marking in 2027, subject to the outcome of the respective regulatory review processes.